undergo a major change; and (c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that (i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism, (ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or (iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism” (Canada, 2001)


“a non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, and thus improves host health” (Gibson and Roberfroid, 1995)


“a live microbial feed supplement which beneficially affects the host animal by improving its intestinal microbial balance” (Fuller, 1989)

Quality factors

Factors necessary to demonstrate that the infant formula, as prepared for market, provides nutrients in a form that is bioavailable and safe as shown by evidence that demonstrates that the formula supports the healthy growth when fed as the sole source of nutrition (FDA, 1996)


Likelihood that an adverse event will occur given exposure to a hazard


A reasonable certainty of no harm or, in some systems, a reasonable balance between costs (harm) and benefits

Term infants

Infants delivered between gestational age of 37 to 42 weeks with birth weights of 2.5 kg or more; safety parameters and committee reviews were limited to healthy term infants with no chronic disease


Thin layer chromatography

Type I error

The probability of falsely rejecting the null hypothesis (i.e., the chance of concluding that a systematic relationship exists in the population when it does not)

Type II error

Failure to detect a real effect; occurs when one fails to reject a false null hypothesis


Tolerable Upper Intake Level


Very low-density lipoprotein


World Health Organization

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